Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-cell Lymphoma

在这项外用罗米迪辛(去脂肽)治疗早期真菌病(一种罕见的皮肤淋巴瘤)的安全性和有效性的临床试验方案中，每个剂量水平的评估包括通过体检、药物耐受性、瘙痒、生活质量、使用色度计对皮肤病的重复评估、使用标准化工作室设置的摄影、用于副作用评估和药代动力学的研究血液，以及用于常规组织学和特殊研究的皮肤活检。我们在本财年遇到了限制皮肤毒性的剂量。因此，我们致力于招募更多的受试者来达到这个剂量水平。然而，由于免疫组织化学分析中的技术问题表明对组蛋白脱乙酰酶的抑制存在不确定性，进一步的招募暂时被搁置。我们一直在与协作者和CTEP合作，在进一步加入之前解决这些技术问题。

In this clinical trial protocol of the safety and efficacy of topical romidepsin (depsipeptide) in early stage mycosis fungoides (a rare type of skin lymphoma), each dose level evaluation includes repeated assessments of skin disease through physical examination, medication tolerability, pruritus, quality of life, erythema with the use of colorimeter, photography using a standardized studio set-up, research blood for side effect evaluation and pharmacokinetics, and skin biopsies for routine histology and special research studies. We encountered a dose limiting skin toxicity within this fiscal year. As a result, we worked on recruiting additional subjects for that dose level. However, due to technical issues in the immunohistochemistry assays indicating uncertainty regarding inhibition of histone deacetylase, further recruitment has been temporarily held. We have been working with collaborators and CTEP to resolve these technical issues prior to further enrollment.